comparison of sar341402 to novolog/novorapid in adult patients with diabetes mellitus also using insulin glargine

Conditions: Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

Summary: primary objective: to demonstrate non-inferiority of sar341402 versus novolog/novorapid in glycated hemoglobin a1c (hba1c) change from baseline to week 26 in participants with type 1 or type 2 diabetes mellitus (t1dm or t2dm) also using lantus®. secondary objectives: * to assess the immunogenicity of sar341402 and novolog/novorapid in terms of positive/negative status and anti-insulin antibody (aia) titers during the course of the study. * to assess the relationship of aias with efficacy and safety. * to assess the efficacy of sar341402 and novolog/novorapid in terms of proportion of participants reaching hba1c lesser than (\<) 7.0% and change in hba1c, fasting plasma glucose (fpg), and self-measured plasma glucose (smpg) profiles from baseline to week 26 and week 52 (only week 52 for hba1c). * to assess safety of sar341402 and novolog/novorapid.

the study consisted of a 2-week screening period, a 26-week treatment period, a 26-week comparative safety extension period, and a 1-day follow-up period. the maximum study duration was 54 weeks per participant and a 1 day safety follow-up.

Eligibility criteria:
inclusion criteria : * participants with t1dm or t2dm (t2dm us only) diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with * novolog/novorapid or insulin lispro (100 u/ml) in the last 6 months prior to screening visit and * insulin glargine (100 u/ml) in the last 6 months prior to screening visit or insulin detemir (levemir®) in the last 12 months prior to screening visit. exclusion criteria: * at screening visit, age under legal age of adulthood. * hba1c \ ) 10% at screening. * less than 1 year on continuous insulin treatment. * use of insulin pump in the last 3 months before screening visit. * participants with incomplete baseline 7-point smpg profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization visit 3. * participants with t1dm: use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening. * participants with t2dm: * use of glucagon-like peptide-1 (glp-1) receptor agonists in the last 3 months before screening visit. * use of oral antidiabetic drugs (oads) not on stable dose in the last 3 months before screening visit (sulfonylureas was discontinued at baseline). * at screening visit, body mass index (bmi) greater than or equal to (\>=) 35 kilogram per meter square (kg/m\^2) in participants with t1dm and \>=40 kg/m\^2 in participants with t2dm. * use of insulin other than: * insulin glargine 100 u/ml and novolog/novorapid or insulin lispro 100 u/ml as part of a multiple injection regimen in the last 6 months before screening visit, or * insulin detemir 100 u/ml in the 12 months before screening visit and novolog/novorapid or insulin lispro 100 u/ml in the last 6 months before screening visit as part of a multiple injection regimen. * status post pancreatectomy. * status post pancreas and/or islet cell transplantation. * hospitalization for recurrent diabetic ketoacidosis in the last 3 months before screening visit. * history of severe hypoglycemia requiring emergency room admission or hospitalization in the last 3 months before screening visit. * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period. * pregnant or breastfeeding women. * women of childbearing potential not protected by highly effective method(s) of birth control. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.